Clinical trial · Interventional
Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors
Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors: a Prospective Multicentre Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was stopped due to negative preliminary analysis, slow recruitment (105 patients over 2,5 years), lack of funding, need for more centers, and the changing treatment landscape (approval of ICIs in combination with other cancer treatments).
Summary
Brief summary (as posted)
The goal of this prospective, multicentre study is to investigate short- and long-term cardiovascular effects in cancer patients treated with immune checkpoint inhibitors (ICIs). The main question\[s\] it aims to answer are: * To investigate troponin and NT-proBNP values in patients receiving ICIs and their association with ICI-induced CV abnormalities and MACEs. * Study the calcium score, systolic, and diastolic (dys)function. * Evaluate associations between patient/disease characteristics / transthoracic echocardiography parameters / electrocardiography parameters and troponin / NT-proBNP levels. Participants will be closely monitored by performing the following additional visits and testing: * Chest CT scan prior to treatment start, after 12 and 24 months. * Consultation with a cardiologist at baseline, 3, 6, 12 and 24 months, who will perform an electrocardiogram and echocardiogram. * One additional blood sample prior to treatment start, after 3, 6, 12 and 24 months. An extra blood sample could be taken in case of sudden heart problems. * Non-invasive endothelial function tests prior to treatment start, after 12 and 24 months.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atherosclerosis | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiac Abnormalities, Variable | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
| Diastolic Dysfunction | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitor-Related Myocarditis | — | UNRESOLVED | — |
| Immune-related Adverse Event | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiology consultation | Procedure | — | UNRESOLVED |
| Chest Computed Tomography (CT) without contrast | Diagnostic Test | — | UNRESOLVED |
| Electrocardiogram | Procedure | — | UNRESOLVED |
| Extra serum sample (7.5 mL) | Diagnostic Test | — | UNRESOLVED |
| Non-invasive endothelial function tests | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cancer patients with a solid tumour eligible for treatment with immune checkpoint inhibitors
- description
- Patients are treated as standard of care
- interventionNames
- Procedure: Cardiology consultation
- Diagnostic Test: Chest Computed Tomography (CT) without contrast
- Procedure: Non-invasive endothelial function tests
- Procedure: Electrocardiogram
- Diagnostic Test: Extra serum sample (7.5 mL)
Primary outcomes (1)
- measure
- The incidence of an elevated hs-TnT above the ULN if the baseline value was normal; or 1.5 ≥ times baseline if the baseline value was above the ULN within the first three months of treatment. The maximum measured value will be taken into account.
- timeFrame
- Preliminary analysis once 50 patients have reached their 3-month cardiac follow-up visit and 3 months after last patient is included.
- description
- For the primary endpoint, the cumulative incidence of troponin elevation will be calculated with death as a competing risk. Cumulative incidences and corresponding 95% confidence intervals will be reported and a cumulative incidence plot will be used to visualize the results.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a solid tumour and will receive one of the following therapies based on current evidence based clinical guidelines: anti-programmed cell death protein-1 (PD-1), anti-programmed cell death ligand-1 (PD-L1) and/or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) therapy * Be literate in Dutch or English Exclusion Criteria: * Prior treatment with immunotherapy (immune checkpoint inhibitors, T-cell transfer therapy, cancer treatment vaccines or immune system modulators). * Patients who will receive ICIs in combination with an additional systemic anti-cancer regimen (chemotherapy, tyrosine kinase inhibitors,…). * Having a known history of human immunodeficiency virus (HIV) infection. * Having a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as detectable RNA via qualitative nucleic acid testing) infection. * Having a diagnosis of immunodeficiency or is receiving chronic/active systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)
References
Publications (1)
- DERIVEDDelombaerde D, De Sutter J, Croes L, Vervloet D, Moerman V, Van de Veire N, Willems AM, Wouters K, Peeters M, Prenen H, Vulsteke C. Extensive CArdioVAscular Characterization and Follow-Up of Patients Receiving Immune Checkpoint Inhibitors: A Prospective Multicenter Study. Pharmaceuticals (Basel). 2023 Apr 20;16(4):625. doi: 10.3390/ph16040625. PMID 37111382